Shots:

• The approval is based on a P-II ZUMA-5 study assessing Yescarta (axicabtagene ciloleucel) in 146 patients aged ≥18rs. with r/r iNHL- prior treated with at least 2L of systemic therapy
• The P-II ZUMA-5 study showed 91% of patients responded to a single infusion of Yescarta- including ~74% of patients in a continued remission @18mos.; mDoR was not yet reached @median follow-up of 14.5 mos. In the safety analysis- grade 3 or higher CRS and neurologic toxicities occurred in 8% and 21% of patients respectively
• Yescarta is the first CAR T-cell therapy approved for indolent follicular lymphoma- follows FDA’s BTD and PR and marks the third approved indication for the therapy

 ­ Ref: Gilead | Image: Businesswire